Comparison of Senza to Commercial Spinal Cord Stimulation for the Treatment of Chronic Pain

NCT ID: NCT01609972

Last Updated: 2015-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 356 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-06-30

Brief Summary

The purpose of this investigational study is to establish the safety and effectiveness of electrical stimulation delivered to the spinal cord in subjects with chronic, intractable pain of the trunk and/or limbs and will be a comparison of the Senza System with commercially available SCS systems.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test

Subjects randomized to this arm will be trialed and implanted with the Nevro Senza System

Group Type: EXPERIMENTAL

Spinal Cord Stimulator

Intervention Type: DEVICE

Non-inferior comparison of implantable spinal cord stimulators

Control

Subjects randomized to this arm will be trialed and implanted with a commercially available SCS system.

Group Type: ACTIVE_COMPARATOR

Spinal Cord Stimulator

Intervention Type: DEVICE

Non-inferior comparison of implantable spinal cord stimulators

Interventions

Spinal Cord Stimulator

Non-inferior comparison of implantable spinal cord stimulators

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Have been diagnosed with chronic, intractable pain of the trunk and/or limbs (VAS ≥ 5) which has been refractory to conservative therapy for a minimum of 3 months.
• Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
• Be 18 years of age or older at the time of enrollment
• Be willing and capable of giving informed consent
• Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion Criteria

• Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
• Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist
• Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
• Have a diagnosis of scoliosis that precludes lead placement
• Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
• Have prior experience with SCS
• Have a condition currently requiring or likely to require the use of MRI or diathermy
• Have metastatic malignant disease or active local malignant disease
• Have a life expectancy of less than 1 year
• Have an active systemic or local infection
• Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
• Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)
• Be concomitantly participating in another clinical study
• Be involved in an injury claim under current litigation
• Have a pending or approved worker's compensation claim

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nevro Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonardo Kapural, MD

Role: PRINCIPAL_INVESTIGATOR

The Center for Clinical Research, Winston-Salem, NC

References

Amirdelfan K, Yu C, Doust MW, Gliner BE, Morgan DM, Kapural L, Vallejo R, Sitzman BT, Yearwood TL, Bundschu R, Yang T, Benyamin R, Burgher AH, Brooks ES, Powell AA, Subbaroyan J. Long-term quality of life improvement for chronic intractable back and leg pain patients using spinal cord stimulation: 12-month results from the SENZA-RCT. Qual Life Res. 2018 Aug;27(8):2035-2044. doi: 10.1007/s11136-018-1890-8. Epub 2018 Jun 1.

Reference Type: DERIVED

PMID: 29858746 (View on PubMed)

Other Identifiers

CA2011 US

Identifier Type: -

Identifier Source: org_study_id